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Document Deluge: Just How Many Extra Regulatory Requirements Will EU Introduce?

The 173-page, condensed EU Medical Devices Regulation is complex enough. But how many additional documents will stakeholders operating in the EU need to comply with? We take a look here.

Europe Regulation Medical Device

Expert: New Ransomware Has Potential To Shut Down Medical Devices

A Symantec cybersecurity expert says that while there have been no reports so far of medical devices being affected by the new Petya ransomware worm, device companies should not underestimate its threat and need to work with partners, including hospitals, to prevent potential harm to patients.

Safety Medical Device United States

Philips Grows Image-Guided Intervention Focus With Spectranetics Buy

In its second acquisition this month and fourth this year, Philips is buying US device maker Spectranetics Corp. for about $2bn to add laser atherectomy catheters to its vascular imaging line-up.

Cardiovascular Cardiology Commercial

Virtual Reality: The New Game In Mental Health Care To Improve Outcomes

Virtual reality is seeing an upsurge in use by mental health practitioners for treating conditions such as post-traumatic stress disorder, panic disorders and anxiety in a safe and controlled manner. With the advent of affordable VR headsets and technological advances, companies and researchers worldwide are seizing on the opportunity to bring such techniques as VR exposure therapy and cognitive behavioral therapy to telemedicine, specialty clinics and directly to consumers to improve outcomes and better lives.

Neurology Innovation Market Intelligence
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Policy & Regulation Explore this Topic

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Timing On User Fee Votes Up In Air, As GOP Delays Senate Health Care Bill Battle

Senate leaders had shoved a floor vote on the five-year device and drug user fee reauthorization bill to the back burner to make room for a pre-July 4 vote on the Senate's Obamacare repeal bill, the Better Care Reconciliation Act. But Senate Majority Leader Mitch McConnell is now delaying a vote to get more votes, a step that could further throw off the timing of FDARA passage.

Legislation Policy United States

US FDA Faces Down Complex Combo Products, Fires Up Oncology Center Of Excellence

FDA officials discuss difficulties dealing with complex combination products, the future of the agency's product centers, and promotion of industry collaboration at the Drug Information Association's annual meeting.

Combination Products Regulation FDA

House Appropriators Will Tell US FDA 'Don't Finalize' LDT Guidance In 2018 Funding Bill

When the House Appropriations Committee takes up the US FDA funding bill for 2018, report language would "prevent the agency from finalizing a guidance on regulating laboratory developed tests," Rep. Rosa DeLauro said at a June 28 Ag/FDA subcommittee markup. The House bill, while maintaining FDA discretionary funding at its prior-year $2.8bn level, also fully appropriates user fee authorizations agreed to by Senate and House Committees in FDA Reauthorization bills in May and June, respectively.

Legislation United States

Draft Drug Executive Order Could Impact Device Regulations

Over the past week a draft executive order has been floating around that aims to deregulate the bio-pharmaceutical industry while also reducing costs for medical products. While aimed at drugs, the order seems to encompass all medical products.

Regulation Pricing Debate

Acting US FDA Chief Scientist Tapped, As Borio Moves To White House Biodefense Detail

FDA promotes Denise Hinton to acting chief scientist after Luciana Borio is detailed to the National Security Council for biodefense work

FDA Policy

Warning Letter Roundup & Recap – June 27, 2017

US FDA did not release any device-related warning letters the week of June 27.

Device Warning Letters Medical Device

Lawmakers Prod Trump To Talk Trade Barriers, Stent Price Caps With India's Modi

US President Trump met with India Prime Minister Modi June 26 in Washington, DC. Trade barriers were one topic on the agenda, and lawmakers in Congress has suggested recent price caps placed on coronary stents in India as one specific issue that should get attention from the leaders.

Policy Trade

EU's MDR: When Three Plus Four Does Not Necessarily Make Seven

Companies hoping to keep their medtech products certified under the current Medical Devices Directive on the market until May 2024 need a reality check, experts say. Things may not be as they seem.

Medical Device Europe

Quality Control & Compliance Explore this Topic

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Latest From Quality Control

Zimmer: Surprised By Biomet Quality Problems, But Responded Before FDA Arrived

Zimmer Biomet's response to a US FDA Form-483 says the firm was unaware of the quality systems woes at the targeted Biomet Warsaw, Ind., plant before its 2015 acquisition of the company. But, it emphasized, comprehensive fixes were in the works even before the 2016 agency inspection that generated more than a dozen substantive observations took place.

Quality Control Compliance

Compliance Corner: Keep 'ALCOA' In Mind To Ensure Quality Data Integrity, Says US FDA Expert

When inspecting a device manufacturing facility, FDA investigators will check a company's quality data to make sure it's Attributable, Legible, Contemporaneous, Original and Accurate – or "ALCOA," the agency's national device expert says.

Quality Control Compliance

Compliance Corner: US FDA Wants Device Firms To Fully Consider Risks To Consumers, Agency Expert Says

Manufacturers that don't consider all possible dangers their products can pose to consumers is a growing problem, FDA's national expert on devices says. Phil Pontikos also is worried that firms aren't putting their best foot forward when using risk assessment tools.

Risk Management Compliance

Commercial Explore this Topic

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Calcivis Ready To Sink Teeth Into UK Market With Imaging Device

Scottish dental technology specialist Calcivis is gearing up for a UK launch of its tooth imaging device. The Edinburgh-based company has developed the Caries Activity Imaging System which can detect calcium deficiencies in tooth enamel that could signal the onset of cavities and thus inform preventive treatment decisions.

Dental Oral StartUps and SMEs Innovation

Latest From Commercial

Medtronic Enters New Outcomes-Based Insulin Pump Deal With Aetna

The device-maker will be on the hook to provide rebates to the health insurer if its self-adjusting insulin pumps don't maintain patients in appropriate glucose ranges, under a newly inked agreement. Medtronic already has a similar arrangement with UnitedHealthcare.

Market Access Reimbursement

Sophia Genetics' AI Brings In More Standardization To Liquid Biopsies

Swiss specialist in data-driven medicine Sophia Genetics has developed a new AI clinical application for clinicians to analyze liquid biopsy results. The technology utilizes the company's artificial intelligence platform SOPHiA

Digital Health Cancer

RepliCel Poised To Partner Up For Precision-Control Dermal Injector

RepliCel Life Sciences is set to unveil in July the first functioning prototype of its next-generation dermal injector, which the company said has already sparked the interest of big dermal filler manufacturers. While the technology had been developed originally to deliver RepliCel's cell therapies for pattern baldness and aging or sun-damaged skin, the company believes the injector's unique features – including electronically-controlled dosing and delivery – allow it to be used in myriad applications.

Dermatology Regenerative Medicine

Philips Completes M&A Hat Trick With Neurodiagnostic Buy

In its third acquisition this year so far, Philips is buying neurodiagnostic firm Electrical Geodesics.

Neurology Diagnostics

Bonesupport Cements Funding With SEK 500m IPO

Swedish orthobiologics company Bonesupport has closed its initial public offering on the Nasdaq Stockholm exchange, raising SEK500m ($57m) from retail and institutional investors.

Orthopedics Financing

UK Medtech Upscales International Plans Ahead of Brexit

As the UK prepared to leave the EU, the local medtech industry, represented by the Association of British Healthcare Industries, has been busy finding ways to make up for any potential restrictions on market access and business development. On June 21, it announced a three-year growth plan, as explained by ABHI managing director of international Paul Benton in this Medtech Insight podcast interview.

United Kingdom Brexit

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

Starts & Stops: Corlife's Decellularized Human Pulmonary Valve Shows Early Promise

Starts & Stops is a regular feature highlighting Medtech Insight editors' picks of noteworthy medtech clinical trial initiations, completions and suspensions each month. News about trials of cardiovascular devices, especially novel heart valve replacement technologies, lead this month's edition, covering mid-May through mid-June.

Starts & Stops Clinical Trials Research & Development

Latest From Research & Development

Positive Data Give DePuy Synthes' Attune Further Knee-Up

Results of a study by the Canadian Radiostereometric Analysis Network show that the tibial base of DePuy Synthes' Attune knee replacement achieves stable fixation out to two years and recently announced results from the UK's National Joint Registry show a 98.1% four-year implant survivorship rate with Attune in a "real-world" setting.

Orthopedics Clinical Trials

Device Week – June 16, 2017

On this week's Medtech Insight podcast: expect digital health guidance documents from US FDA soon, the agency’s commissioner says; FDA optimistic it will push out a final version of a 3D printing manufacturing guidance this year; US government releases data on the number of people who would lose health insurance under the American Health Care Act; Wells Fargo report fingers which device types would be most impacted by Trumpcare; a look at FDA approval and clearance trends, including a noticeable increase in 510(k)s; new clinical data releases discussed.

FDA Digital Health

INS 2017: Neuromodulation's Future Features Innovative Power Source, Materials And Treatment Protocols

Neuromodulation technology is advancing at breakneck speed, as physicians, academic, and industry innovators deepen their understanding of the field and learn what works and what doesn't. At the Innovations Day held during the 13th world congress of the International Neuromodulation Society in Edinburgh, Scotland, Medtech Insight highlights the notable new techs that are in the pipeline of emerging companies.

Neurology Innovation

OUS Approvals Analysis: IVDs Lead A Slow Month

Only 10 approvals from outside the US were recorded in May in Medtech Insight's approvals tracker. Half of those were for in vitro diagnostics, including three for companion diagnostic for cancer drugs.

Approvals Innovation

Start-Up Spotlight: LensGen, Eye On The Presbyopia Prize

Restoring the eyes' ability to accommodate and seamlessly focus on near and far objects continues to be the holy grail in ophthalmology. Accommodating intraocular lenses offer one approach to tackle presbyopia and allow patients the possibility of eschewing reading glasses. LensGen is one company going down that road and it successfully raised $21m in series A financing – with major optical lens maker Hoya among its backers – in April to advance its fluid-based accommodating IOL, Juvene.

Ophthalmology Innovation

ASCO 2017: Myriad's MyRisk; Nanobiotix' NBTXR3; Chronix' CNI Test; Sirtex SIR-Spheres; ANGLE’s Parsortix CTC Harvester

Over 30,000 oncologists and other health professionals attended the 2017 American Society of Clinical Oncology annual meeting in Chicago, June 2-6. This year's meeting included several presentations on emerging cancer diagnostic and device treatment strategies, including genetic tests, liquid biopsy systems, radioenhancers, and microspheres intended to improve chemotherapy outcomes.

Cancer In Vitro Diagnostics
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